Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sympathectomy
Sympathicotomy
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring sympathectomy, sympathicotomy, heart rate variability,
Eligibility Criteria
Inclusion Criteria:
- Age more than 18 years
- Severe hyperhidrosis
Exclusion Criteria:
- Contraindications for general anaesthetic procedure and/or for selective endotracheal intubation
- Previous pleural or lung diseases that make difficult the access to pleural cavityù
- Cardiac diseases and/or taking medications with cardiac effects
- Secondary hyperhidrosis including hyperthyroidism, acute and chronic infections, malignancy, and immunologic disorder
- Mild or moderate palmar hyperhidrosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sympathectomy Group
Sympathicotomy Group
Arm Description
Excision of ganglia at T3 level
Resection of sympathetic chain at T3 level
Outcomes
Primary Outcome Measures
Heart Rate (HR) measured in beats/min
Secondary Outcome Measures
Post-operative complications
Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)
Full Information
NCT ID
NCT02733497
First Posted
April 5, 2016
Last Updated
April 9, 2016
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT02733497
Brief Title
Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis
Official Title
Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis: Results Of A Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Essential palmar hyperhidrosis (EPH) is a pathological condition of excessive sweating of the hands due to an unexplained over-activity of the T2 and T3 sympathetic fibers. Endoscopy Thoracoscopic Sympathectomy (ETS) is the treatment of choice in patients with EPH refractory to medical treatment .
The cardiac sympathetic activity is mainly controlled by cervical sympathetic fibers but anatomic studies have showed that "accessory" fibers from the T2 and T3 sympathetic ganglia come to the heart and influence its function.
Heart Rate Variability (HRV) is a simple and non-invasive method based on electrocardiogram to evaluate the sympathovagal balance at the sino-atrial level. Several studies have found that ETS caused a decrease of heart rate (HR), an increase of HR variability (HRV) and a shift of sympathovagal balance toward parasympathetic tone but remains unclear if these changes are associated with the extend of ETS.
Thus, in the present study the investigator performed a prospective analysis of HRV function in patients with EPH undergoing different sympathetic denervations as sympathectomy and sympathicotomy with the hypothesis that cardiac autonomic changes could be associated with the extend of sympathetic resection.
Detailed Description
It was an unicenter prospective study performed at Thoracic Surgery Unit of Second University of Naples. Patients with severe EPH were randomly assigned to Sympathectomy or Sympathicotomy Group in 1:1 ratio .
Bilateral ETSs were performed in a one-stage procedure by the same surgeon. General anaesthesia using single-lung ventilation technique was performed and patient was placed in standard lateral thoracotomy position. Immediately after the induction of anaesthesia, a local infiltration with 2% lidocaine and epinephrine was injected at each port 5 minutes before the incision to reduce postoperative pain. The first port was placed in the 3th intercostal space below and anterior to inferior angle of scapula and through that a 10 mm 30 degree camera was inserted. A second 5 mm working port was placed at the same intercostal space in the anterior axillary line. After identification of sympathetic chain, in Sympathectomy Group the T3 ganglion was excised at the top of the third rib while in Sympathicotomy Group the sympathetic chain was resected between T2-T3 ganglia at the same level but the T3 ganglion was left intact. At the end of the procedure, a 16 F drainage was inserted through the port and the lung was re-inflated to allow the air drainage from pleural cavity and to prevent pneumothorax. The drain was subsequently removed.
All measurements on cardiac autonomic function were performed one week before ETS and different post-operative time-points (7 days, 1, 3 and 6 months after ETS). The results were prospectively registered and then retrospectively analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
sympathectomy, sympathicotomy, heart rate variability,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sympathectomy Group
Arm Type
Active Comparator
Arm Description
Excision of ganglia at T3 level
Arm Title
Sympathicotomy Group
Arm Type
Active Comparator
Arm Description
Resection of sympathetic chain at T3 level
Intervention Type
Procedure
Intervention Name(s)
Sympathectomy
Intervention Description
Resection of ganglia at T3 level
Intervention Type
Procedure
Intervention Name(s)
Sympathicotomy
Intervention Description
Cutting of symptahetic chain at T3 level without ganglia excision
Primary Outcome Measure Information:
Title
Heart Rate (HR) measured in beats/min
Time Frame
7 days, 1, 3 and 6 months after operation
Secondary Outcome Measure Information:
Title
Post-operative complications
Time Frame
Post-operative time and 7 days, 1, 3 and 6 months after operation
Title
Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)
Time Frame
1, 3 and 6 months after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age more than 18 years
Severe hyperhidrosis
Exclusion Criteria:
Contraindications for general anaesthetic procedure and/or for selective endotracheal intubation
Previous pleural or lung diseases that make difficult the access to pleural cavityù
Cardiac diseases and/or taking medications with cardiac effects
Secondary hyperhidrosis including hyperthyroidism, acute and chronic infections, malignancy, and immunologic disorder
Mild or moderate palmar hyperhidrosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Santini, MD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17404794
Citation
Katara AN, Domino JP, Cheah WK, So JB, Ning C, Lomanto D. Comparing T2 and T2-T3 ablation in thoracoscopic sympathectomy for palmar hyperhidrosis: a randomized control trial. Surg Endosc. 2007 Oct;21(10):1768-71. doi: 10.1007/s00464-007-9241-9. Epub 2007 Apr 3.
Results Reference
background
PubMed Identifier
10219553
Citation
Tedoriya T, Sakagami S, Ueyama T, Thompson L, Hetzer R. Influences of bilateral endoscopic transthoracic sympathicotomy on cardiac autonomic nervous activity. Eur J Cardiothorac Surg. 1999 Feb;15(2):194-8. doi: 10.1016/s1010-7940(98)00309-1.
Results Reference
background
PubMed Identifier
19258086
Citation
Cruz J, Sousa J, Oliveira AG, Silva-Carvalho L. Effects of endoscopic thoracic sympathectomy for primary hyperhidrosis on cardiac autonomic nervous activity. J Thorac Cardiovasc Surg. 2009 Mar;137(3):664-9. doi: 10.1016/j.jtcvs.2008.07.021. Epub 2008 Sep 24.
Results Reference
background
PubMed Identifier
27889103
Citation
Fiorelli A, Messina G, Chiodini P, Costanzo S, Viggiano A, Monda M, Vicidomini G, Santini M. Cardiac Autonomic Changes After Thoracic Sympathectomy: A Prospective, Randomized Study. Ann Thorac Surg. 2017 Jan;103(1):216-224. doi: 10.1016/j.athoracsur.2016.10.055. Epub 2016 Nov 23.
Results Reference
derived
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Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis
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